Recent Updates
Recently added Catalysts

Adalimumab

Phase 3

Plaque Psoriasis | Monoclonal antibody | Dermatology |Alvotech|Last Updated: May 5, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment413

FDA Designations

No designations recorded

Clinical trial landscape

Adalimumab · 5 trials · 4 indications

Phase 3 2Phase 1 3
NCT04224194Auto-injector Real Life Handling in PatientsRA
COMPLETED107 Analytics
NCT03849404Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque PsoriasisPlaque Psoriasis
COMPLETED413 Analytics
PHASE3COMPLETED
Auto-injector Real Life Handling in Patients
RA
NCT04224194107
Unlock trial analytics
PHASE3COMPLETED
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis
Plaque Psoriasis
NCT03849404413
Unlock trial analytics

Study Endpoints

Primary Endpoints

percentage of successful self-injections patient rated
up to the Week 8

The percentage of successful self-injections as reported in the questionnaires completed by the patients (Patient Assessment Tool, Question 1), analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.

percentage of successful self-injections site staff rated
up to the Week 8

The percentage of successful self-injections as reported in the questionnaires completed by the trial site personnel (Observer Assessment Tool, Question 1) , analyzing all self-injections occurring after the trained self-injection. The higher the % the better the result.

Psoriasis Area and Severity Index (PASI)
Baseline to Week 16

Percent (%) change in Psoriasis Area and Severity Index (PASI)

Area under the plasma concentration-time curve AUC0-t
From baseline to day 64

Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector

Area under the plasma concentration-time curve AUC0-inf
From baseline to day 64

Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector

Maximum serum concentration
From baseline to day 64

Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector

Change from baseline blood pressure at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Measurement of blood pressure (systolic and diastolic in mm Hg)

Change from baseline heart rate at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Measure of heart rate (beats per minute)

Change from baseline body temperature at 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing
Predose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 64 days post dosing

Measurement of oral temperature (Celsius degree)

Change from baseline electrocardiogram at 1, 2, 5, 9, 64 days post dosing
Predose and 1, 2, 5, 9, 64 days post dosing

Analysis of 12-lead electrocardiogram

Change from baseline red blood cells at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure red blood cells count, (unit/mm3)

Change from baseline haemoglobin at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure haemoglobin (g/L)

Change from baseline white blood cells at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure white blood cells count, (unit/mm3)

Change from baseline platelets at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure platelets count, (unit/mm3)

Change from baseline blood gamma glutamyl transferase at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure gamma glutamyl transferase (UI/L)

Change from baseline blood aspartate aminotransferase at 2, 3, 5, 9, 64 days post
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure aspartate aminotransferase (UI/L)

Change from baseline blood alanine aminotransferase at 2, 3, 5, 9, 64 days post
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure alanine aminotransferase (UI/L)

Change from baseline blood potassium at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure potassium (mmol/L)

Change from baseline blood sodium at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure sodium (mmol/L)

Change from baseline blood calcium at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure calcium (mmol/L)

Change from baseline blood phosphate at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure phosphate (mmol/L)

Change from baseline blood chloride at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure chloride (mmol/L)

Change from baseline blood bicarbonate at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure bicarbonate (mmol/L)

Change from baseline blood creatinine at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure creatinine (micromol/L)

Change from baseline blood bilirubin at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure Bilirubin (micromol/L)

Change from baseline international normalised ratio at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure international normalised ratio

Change from baseline prothrombin time at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure prothrombin time (sec)

Change from baseline partial prothrombin time at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure partial prothrombin time (sec)

Change from baseline activated partial thromboplastin time at 2, 3, 5, 9, 64 days post
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure activated partial thromboplastin time (sec)

Change from baseline thrombin time at 2, 3, 5, 9, 64 days post
Predose and 2, 3, 5, 9, 64 days post dosing

Blood collection to measure thrombin time (sec)

Change from baseline urine leucocytes at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Urine sample collection to measure leucocytes

Change from baseline urine glucose at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Urine sample collection to measure glucose

Change from baseline urine protein at 2, 3, 5, 9, 64 days post dosing
Predose and 2, 3, 5, 9, 64 days post dosing

Urine sample collection to measure protein

Secondary Endpoints

frequency of any autoinjector handling events during the self-injection process
Up to week 8
Psoriasis Area and Severity Index (PASI)
Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50
Pain, Tenderness, Erythema and Swelling
From baseline to day 64
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Interventional, Single arm to evaluate autoinjector handlingOTHERTo assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who selfinject AVT02 (adalimumab) subcutaneously (SC).
AVT02 100mg/mL (Adalimumab Biosimilar)EXPERIMENTALPatients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48
EU-Humira 100mg/mL (Adalimumab Originator)EXPERIMENTALPatients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48
AVT02 100mg/mL in PFSEXPERIMENTALPrefilled Syringe Arm
AVT02 100mg/mL in AutoinjectorEXPERIMENTALAutoinjector Arm
AVT02 100mg/mLEXPERIMENTALBiosimilar Adalimumab AVT02
EU-Humira 100mg/mLACTIVE_COMPARATOREU Approved Adalimumab originator Humira
US-Humira 100mg/mLACTIVE_COMPARATORUS licensed Adalimumab originator Humira
AVT02 100 MG/MLEXPERIMENTALSingle subcutaneous injection of 40 mg of AVT02 (100MG/ML)
Adalimumab 100 MG/ML [HUMIRA]ACTIVE_COMPARATORSingle subcutaneous injection of 40 mg of Adalimumab (100MG/ML) \[HUMIRA\]

Interventions

NameTypeDescription
AdalimumabCOMBINATION_PRODUCTCombined product as Drug is delivered through an autoinjector pen on which real-life patient handling experience is assessed.
Adalimumab 100 MG/ML [Humira]DRUGprefilled syringe at a concentration of 100MG/ML and delivering 40MG of adalimumab, as a single dose on day 1 day 1
AVT02 100MG/MLDRUGprefilled syringe at a concentration of 100MG/ML delivering 40MG of AVT02, as a single dose on day 1 day 1
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patient is male or female, 18 to 80 years of age, inclusive, at time of Screening. * Patients diagnosed with RA for at least 4 months and currently classified according to the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism classification criter...

Countries:GeorgiaUkraineEstoniaPolandNew ZealandAustralia
Unlock Eligibility Criteria